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Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
femtosecond laser system arcuate corneal incision
Manual LRI
Sponsored by
Gainesville Eye Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring astigmatism, limbal relaxing incisions

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

  • are willing and able to understand and sign an informed consent;
  • are willing and able to attend all study visits;
  • are more than 40 years of age, of either gender and any race;
  • are presenting for cataract surgery or refractive lens exchange with a desire to reduce astigmatism and will be implanted with a non-toric lens
  • have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
  • have 0.50 D to 1.75 D of regular corneal astigmatism
  • have potential acuity of 20/25 or better
  • Are scheduled to have a non-toric monofocal intraocular lens (IOL) (SN60WF) lens implanted in both eyes

Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

  • Irregular astigmatism (e.g. keratoconus)
  • Corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye)
  • Monocular status (e.g. amblyopia)
  • Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty)
  • Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
  • Diabetic retinopathy
  • Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)
  • History of retinal detachment
  • Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect post-operative visual acuity.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Sites / Locations

  • Gainesville Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Femtosecond limbal relaxing incision (LRI)

Manual LRI

Arm Description

Eyes will be treated with arcuate incisions from a femtosecond laser system.

Eyes will be treated with arcuate incisions completed manually with a blade.

Outcomes

Primary Outcome Measures

Residual Refractive Astigmatism
Residual refractive astigmatism measured in diopters

Secondary Outcome Measures

Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D)
The number of eyes with residual refractive astigmatism < 0.50 diopters (D)
Uncorrected Monocular Distance Visual Acuity
Uncorrected monocular distance visual acuity in logMAR
Spherical Equivalent Refraction
Spherical equivalent refraction in diopters
Corneal Astigmatism
Anterior corneal astigmatism

Full Information

First Posted
October 11, 2019
Last Updated
September 3, 2021
Sponsor
Gainesville Eye Associates
Collaborators
Science in Vision
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1. Study Identification

Unique Protocol Identification Number
NCT04126174
Brief Title
Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes
Official Title
Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gainesville Eye Associates
Collaborators
Science in Vision

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to compare the effectiveness of LenSx laser arcuate relaxing incisions vs. manual (blade) arcuate relaxing incisions in patients with low, but significant, levels of astigmatism.
Detailed Description
This study is a comparative, prospective, randomized contralateral eye study of visual outcomes after LenSx laser arcuate relaxing incisions utilizing the Woodcock nomogram at 90% thickness vs. manual (blade) fixed keratome diamond knife at 600 microns for arcuate relaxing incisions utilizing the Donnenfeld nomogram. Subjects will be assessed pre-operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction and corneal astigmatism measurement with the Lenstar and slit lamp exam.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
astigmatism, limbal relaxing incisions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Contralateral eye study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femtosecond limbal relaxing incision (LRI)
Arm Type
Active Comparator
Arm Description
Eyes will be treated with arcuate incisions from a femtosecond laser system.
Arm Title
Manual LRI
Arm Type
Active Comparator
Arm Description
Eyes will be treated with arcuate incisions completed manually with a blade.
Intervention Type
Device
Intervention Name(s)
femtosecond laser system arcuate corneal incision
Other Intervention Name(s)
LRI
Intervention Description
Corneal arcuate incision made either with a blade (manual) or femtosecond laser system.
Intervention Type
Other
Intervention Name(s)
Manual LRI
Intervention Description
Manual LRI
Primary Outcome Measure Information:
Title
Residual Refractive Astigmatism
Description
Residual refractive astigmatism measured in diopters
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D)
Description
The number of eyes with residual refractive astigmatism < 0.50 diopters (D)
Time Frame
3 months
Title
Uncorrected Monocular Distance Visual Acuity
Description
Uncorrected monocular distance visual acuity in logMAR
Time Frame
3 months
Title
Spherical Equivalent Refraction
Description
Spherical equivalent refraction in diopters
Time Frame
3 months
Title
Corneal Astigmatism
Description
Anterior corneal astigmatism
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. are willing and able to understand and sign an informed consent; are willing and able to attend all study visits; are more than 40 years of age, of either gender and any race; are presenting for cataract surgery or refractive lens exchange with a desire to reduce astigmatism and will be implanted with a non-toric lens have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) have 0.50 D to 1.75 D of regular corneal astigmatism have potential acuity of 20/25 or better Are scheduled to have a non-toric monofocal intraocular lens (IOL) (SN60WF) lens implanted in both eyes Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. Irregular astigmatism (e.g. keratoconus) Corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye) Monocular status (e.g. amblyopia) Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty) Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) Diabetic retinopathy Macular pathology (e.g. age-related macular degeneration, epiretinal membrane) History of retinal detachment Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect post-operative visual acuity. Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clayton G Blehm, MD
Organizational Affiliation
Gainesville Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gainesville Eye Associates
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes

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